[Phase II study of cisplatin in cervical and endometrial carcinomas].

A phase II group study of cisplatin for cervical and endometrial carcinomas was carried out in 19 institutes throughout Japan. The patients entered consisted of 62 women with cervical and 7 with endometrial carcinoma of whom 39 and 4 were evaluable, respectively. Cisplatin was administered in either of two regimens; 10-20 mg/m2 i.v., on days 1-5, or 50-100 mg/m2 i.v., on day 1, every 3 to 4 weeks. The responders comprised 4 CRs and 10 PRs for cervical carcinoma and 1 CR and 2 PRs for endometrial carcinoma, and the response rates were 35.9% and 75.0%, respectively. The response rates by histological classification were 39.4% (13/33) for squamous cell carcinoma and 16.7% (1/6) for non-squamous cell carcinoma. Response rates analysed by lesion site were 33.3% for primary tumors, 36.8% for local lesions and 33.3% for metastases. Furthermore, the response rate among patients without any prior chemotherapy was 44.4% vs. 16.7% for those with prior chemotherapy. Adverse effects included nausea and vomiting (95.3%), anorexia (93%), anemia (72.1%), leucopenia (60.5%) and elevation of BUN (16.3%). Adverse effects were tolerable. We concluded from these results that cisplatin is among the most efficacious and useful drugs against cervical (and endometrial) carcinoma(s).

[Clinical studies on aztreonam in infections in obstetrics and gynecology].

Clinical effect was studied for aztreonam (AZT) on 2 patients being treated for malignant tumors. One-two grams of AZT was administered b.i.d. by intravenous drip infusion for 6-7 days. In case 1 with pyometra, there were excellent improvements in WBC, CRP and fever pattern. Unfavorable BUN and S-Cr. values were found, but these were considered to be side effects due to cisplatin. These improved finally, and clinical effect was also excellent. Case 2, a urinary tract infection + prophylactic postoperative administration case, was treated in combination with another drug presuming mixed infection and AZT was shown to be effective clinically and overall. No side effects in cases 1 or 2 were considered to be due to AZT.

[Phase II study of 4'-O-tetrahydropyranyl-adriamycin (THP-ADM) in patients with gynecological cancer].

We conducted a joint phase II study in 76 patients with gynecological cancer (42 patients with ovarian cancer, 22 patients with cervical cancer, 10 patients with endometrial cancer and 2 patients with vaginal cancer). The response rate was 25.0% in the patients with ovarian cancer, 13.3% in those with cervical cancer, and 28.6% in those with endometrial cancer. The overall response rate was 23.1%. When the patients were classified according to dose schedules, the highest response rate was obtained in the group administered THP-ADM at a dose of 60 mg per body by single i.v. injection at 3-week intervals. Such side effects as myelosuppression and gastrointestinal disturbances were observed, but alopecia, a marked side-effect of ADM administration, was mild, and no cardiac toxicity was seen in any of the patients.